Regulatory Compliance Solutions

  1. Quality, Compliance, And Regulatory Services For Life Sciences 12/21/2020

    The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

  2. Particle Loss Studies 12/15/2025

    Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.

  3. Keep A Close Eye On Quality With Excipients For Drug Formulation 8/27/2025

    Developing ophthalmic drugs demands precision and compliance. Explore a specialized excipient portfolio that supports optimal formulation to enhance stability, sterility, and patient comfort.

  4. Advanced Liquid Handling Workstation For Clinical, GLP, And QC Facilities 10/10/2025

    Designed for regulated labs, this automation platform combines speed, flexibility, and built-in compliance tools to meet FDA 21 CFR Part 11 standards to support secure, high-throughput workflows.

  5. LearnGxP Master Catalog 4/24/2026

    Advance organizational expertise with structured training designed for technical mastery. Explore specialized lessons that empower teams to optimize complex workflows and maintain compliance.

  6. Flex-Durable Pump Tubing For Irradiated Single-Use Assemblies 5/29/2026

    Reliable fluid transfer demands tubing that resists failure and maintains flow under pressure. Learn about a composite design that enhances durability and consistency, supporting longer operational life.

  7. Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements 4/14/2023

    As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

  8. Freeze Your Device Design With An Integrated, Verified PFA System 4/20/2026

    Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.

  9. Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) 12/1/2022

    The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).

  10. Time To Embrace The Digital CPV 6/2/2026

    Automate data acquisition, monitor trends in real time, and respond to deviations proactively.